GUEST COLUMNISTS

• An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?

  FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

• Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty

  Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

• Is Your Supply Chain Ready For The End Of Class VI?

  Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

• Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs

  Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system. 

• Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline

  Applying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.

• Complete Response Letters For CGTs Share This Common Theme

  One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

• Your 7 Decisions To Make Before MES Configuration

  Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

• The Orange Book's Blind Spot: Process Stability And Capability

  The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.